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CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
NF - Identification A (Sodium)
Passes Test
NF - Identification B (pH)
≥11.0
NF - Insoluble Substances and Organic Matter
Passes Test
NF - Potassium (K)
≤0.5 %
NF - Carbonate (as Na₂CO₃)
≤3.0 %
NF - Total Alkali
95.0 - 100.5 %
NF - Content of Sodium
54.0 - 59.8 %
ChP -Assay
97.0 - 100.5 %
ChP -Sodium carbonate
2.0% max
ChP -Identification
Passes Test
ChP -Alkalinity
Passes Test
ChP -Clarity and color of solutionÂ
Passes Test
ChP -ChlorideÂ
0.005 % max
ChP -SulfateÂ
0.015 % max
ChP -PotassiumÂ
Passes Test
ChP -Aluminum and ironÂ
 0.1% max
ChP -IronÂ
0.001% max
ChP -Heavy metalÂ
20 ppm max
EP/BP - Identification A
Passes Test
EP/BP - Identification B
Passes Test
EP/BP - Carbonate (as Na₂CO₃)
≤2.0 %
EP/BP - Appearance of Solution
Passes Test
EP/BP - Chloride (Cl)
≤200 ppm
EP/BP - Sulfate (SOâ‚„)
≤200 ppm
EP/BP - Iron (Fe)
≤10 ppm
EP/BP - Assay (NaOH)
97.0 - 100.5 %
JP - Assay
95.0 - 101.0 %
JP - Identification A
Passes Test
JP - Identification B
Passes Test
JP - Clarity and Color of Solution
Passes Test
JP - Chloride (Cl)
≤0.050 %
JP - Heavy Metals (as Pb)
≤30 ppm
JP - Potassium (K)
Passes Test
JP - Carbonate (as Na₂CO₃)
≤2.0 %
JP - Mercury (Hg)
Passes Test
Endotoxin Concentration (EU/g)
≤5
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product.
Elemental Impurities (USP 232, EP 5.20) - Information on elemental impurities for this product is available on the associated Product Regulatory Data Sheet and elemental impurity profile report.